Stability Testing for Dietary Supplements

Duration: 60 Minutes
The purpose is to present recommendation for supporting the voluntary shelf-life (expiration) dating claims of dietary supplements. The purpose of stability testing is to provide evidence on how the quality of formulation varies with time under the influence of a variety of environmental factors. Stability testing permits the establishment of recommended storage conditions and shelf lives.
Stability Testing
Instructor: Kenneth F. Miles
Product ID: 501914
Objectives of the Presentation
  • Introduction of a Stability Testing Plan and Program
  • Selection of Batches
  • Types of Testing
  • Container-closure Systems
  • Shelf-life Protocol
  • Shelf-life Evaluation/Study Report
Why Should you Attend
The most relevant scientific data are from stability (shelf-life) studies. It is recommended that manufacturers have a written testing program designed to assess the stability characteristics of the dietary supplement, and to use the results of stability testing to determine appropriate storage conditions and expiration dates. Attend this training to learn more about the Stability Testing for Dietary Supplements.

Areas Covered
  • Introduction
  • Scope
  • Glossary
  • General principles of shelf-life studies
  • Selection of batches
  • Bracketing or Matrixing
  • Types of testing
  • Container-closure systems
  • Types of sudies
  • Shelf-life study protocol
  • Shelf-life evaluation
Who will Benefit
Senior Management, Regulatory Affairs, Quality Assurance Analyst & Management, Quality Control Analyst & Management, Stability Testing Department Personnel & Management, Packaging Personnel & Management, Design Personnel & Management

Topic Background
Stability testing is required to provide evidence on the quality of a product, substance or material as it varies with environmental factors such as temperature, humidity, light and the passage of time for shelf-life and storage conditions.
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Instructor Profile:
Dr. Kenneth F. Miles is a seasoned professional in Quality, Regulatory and Clinical affairs and development strategy for drugs, biologics, medical devices and combination products. He has worked in senior quality and regulatory roles in the medical products industry for more than 20 years. Dr. Miles has worked for a number of large and small pharmaceutical, biotech and medical device companies. He also interfaced with FDA at Local, District and Centre levels and has dealt with several foreign ministries to bring companies into compliance. He has set up regulatory and quality systems for countries around the world, including the Pacific Rim, Europe and South America. He is the senior member of the American Society for Quality, (Certified Quality Engineer) and member and Fellow of Regulatory Affairs Professional Society (Certified Regulatory Affairs). Dr. Kenneth F. Miles is the recipient of the GMP Institute Hall of Fame Award.


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